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Relative Bioavailability and Food Effect Study for GSK163090 in Healthy Male and Female Volunteers

NCT00536679 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-08-03

No results posted yet for this study

Summary

The study will consist of a screening period, 3 treatment periods and a post-treatment follow-up. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose

Conditions

  • Depressive Disorder and Anxiety Disorders

Interventions

DRUG

GSK163090 capsule, fasted

GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water.

DRUG

GSK163090 Tablet, fasted

GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water.

DRUG

GSK163090 Tablet, fed

GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-20
Primary Completion
2007-11-05
Completion
2007-11-05

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536679 on ClinicalTrials.gov